A pragmatic single-blind randomised controlled trial and health economic evaluation of leukotriene receptor antagonists in primary care at steps two and three of the national asthma guidelines

ISRCTN	ISRCTN99132811
DOI	https://doi.org/10.1186/ISRCTN99132811
Protocol serial number	HTA 98/34/05
Sponsor	Department of Health (UK)
Funder	NIHR Health Technology Assessment Programme - HTA (UK)

Submission date: 25/04/2003
Registration date: 25/04/2003
Last edited: 11/10/2011

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Respiratory

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof David Price
Scientific

Department of General Practice & Primary Care
University of Aberdeen
Foresterhill Health Centre
Westburn Road
Aberdeen
AB25 2AY
United Kingdom

Phone	+44 (0)1224 554588
Email	david@respiratoryresearch.org

Study information

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study acronym	ELEVATE
Study objectives	This study will evaluate the relative clinical effectiveness and costs at time points over a two year follow-up (short-term specifically at two months and long-term over two years) of Leukotriene Receptor Antagonist (LTRA) prescription in primary care. PRIMARY: To compare quality of life with LTRAs against alternative treatments at steps two and three of the guidelines, comparing resource use over a two year period to the NHS and patients (on an intention to treat basis), using either a cost-minimisation or cost-effectiveness approach. The choice will depend on whether differences emerge between the groups over two years with particular emphasis on two months and two years (i.e. short and long-term). SECONDARY: To compare other clinically relevant asthma outcomes between two treatment groups at two months and throughout the two year study (see Primary outcomes). The design enables this to be compared at step two with inhaled steroid prescription and at step three with add-on of a long-acting beta agonist prescription. Its pragmatic design coupled with clinical trial rigour: 1. Concealed randomised allocation of patients, 2. Blinded procedures for recording and collection of outcomes data (by a non-clinician) and blinded data analysis should produce results that are both valid and applicable to primary care as a whole. Please note that, as of 25 January 2008, the start and end dates of this trial were updated from 1 January 2000 and 30 April 2003 to 1 October 2001 and 28 February 2007, respectively.
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Asthma
Intervention	LTRAs versus alternative treatment
Intervention type	Drug
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Leukotriene receptor antagonist
Primary outcome measure(s)	1. Need for further treatment intervention 2. Frequency of exacerbations 3. Short-acting beta agonist use 4. Hospitalisations 5. Time off work 6. Daily inhaled steroid dose (step three) 7. Asthma symptoms 8. Morning and diurnal variation in peak flow 9. Those with eczema/rhinitis comparative change in disease assessment
Key secondary outcome measure(s)	Not provided at time of registration.
Completion date	28/02/2007

Eligibility

Participant type(s)	Patient
Age group	Not Specified
Sex	All
Target sample size at registration	720
Key inclusion criteria	Not provided at time of registration.
Key exclusion criteria	Not provided at time of registration.
Date of first enrolment	01/10/2001
Date of final enrolment	28/02/2007

Locations

Countries of recruitment

United Kingdom
Scotland

Study participating centre

Department of General Practice & Primary Care

Aberdeen
AB25 2AY
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Peer reviewed?	Patient-facing?
Results article	Beta-2 results	01/10/2010	Yes	No
Results article	Corticosteroid results	01/10/2010	Yes	No
Results article	results	01/05/2011	Yes	No
Results article	results	05/05/2011	Yes	No